NCT01023243

Brief Summary

The investigators propose to use a Natural Language Processing System (NLP) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a randomized trial, we plan to use a previously validated mailed survey (NCQA Provider Recognition Program) that requests information on the last foot exam, use of aspirin and tobacco. Patients who have been identified by NLP as not having had a foot exam will be randomized into treatment and control arms. Both arms will receive an informational letter; with a second mailing to nonresponders after one month, describing the key strategies for effective patient-physician communication during the clinical encounter. The treatment arm will also receive an informational letter and patient education brochure containing key messages about the importance of regular foot examinations. NLP will be repeated after 6 months to compare the impact of the patient education materials.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2008

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

December 9, 2008

Last Update Submit

January 5, 2016

Conditions

Diabetes

Keywords

foot examhealth servicespractice improvementqualitypreventive servicesNatural Language Processing

Outcome Measures

Primary Outcomes (1)

  • Completion of foot exam

    6 months post intervention

Secondary Outcomes (1)

  • Patient report in validation of Natural Language Processing

    6 months

Study Arms (3)

1 CAre of the Feet for Those at Risk

PLACEBO COMPARATOR

secular trends for physician documentation in the medical record for care of the feet for high risk patients

Other: Brochure: Care of the Feet for Those at RiskOther: Quality Survey: foot exam, tobacco and aspirin use

Care of the feet for those at risk

ACTIVE COMPARATOR

the impact of 1) patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam and 2) patient education material: Care of the Foot For Those at Risk, on documentation of foot examination in the medical record

Other: Quality Survey: foot exam, tobacco and aspirin use

Impact of Quality Survey

ACTIVE COMPARATOR

Impact of patient survey regarding last foot exam, tobacco and aspirin use on documentation of foot exam in the medical record

Other: Brochure: Care of the Feet for Those at Risk

Interventions

Brochure: Care of the Feet for Those at RiskOTHER

Patient education materials and key messages for care of the feet for those patients at risk

Also known as: Care of the Feet For Those at Risk
1 CAre of the Feet for Those at RiskImpact of Quality Survey
Quality Survey: foot exam, tobacco and aspirin useOTHER

NCQA Patient Survey

Also known as: Care of the Feet For Those at Risk
1 CAre of the Feet for Those at RiskCare of the feet for those at risk

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary care patients with diagnosis of diabetes

You may not qualify if:

  • unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Pakhomov S, Bjornsen S, Hanson P, Smith S. Quality performance measurement using the text of electronic medical records. Med Decis Making. 2008 Jul-Aug;28(4):462-70. doi: 10.1177/0272989X08315253. Epub 2008 May 13.

    PMID: 18480037BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Gregory a Bartel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Steven A Smith, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 2, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

US(1)